Less than four months after completing patient enrollment, Skye Bioscience, Inc., announced that its phase 2a clinical study evaluating SBI-100 ophthalmic emulsion (OE) for the treatment of primary open-angle glaucoma (POAG) and ocular hypertension (OHT) did not meet its primary objective.
Oh dear … let’s start with SBI-100.
Formulated as an eye drop, SBI-100 OE is a cannabinoid receptor type 1 (CB1) agonist administered topically into the eye via nanoemulsion.
Its purpose: The synthetically-derived molecule is a prodrug of tetrahydrocannabinol (THC) designed to target the CB1 receptor.
- Why this is key: The CB1 receptor modulates intraocular pressure (IOP).
Gotcha. Now a rundown on this trial.
The double-masked, randomized, placebo-controlled study (NCT06144918) enrolled 54 patients (aged 18+) with POAG or OHT who were also diagnosed with elevated IOP.
Participants were randomly assigned to an interventional treatment of one of the following:
- 0.5% SBI-100 OE (5 mg/mL)
- 1.0% SBI-100 OE (10 mg/mL)
- Placebo
The dosings: One drop of one of the three interventions was administered in each eye, twice a day (BID)—morning and evening—for 14 days.
And the objective?
The company reported its primary endpoint to be change in diurnal IOP in the treatment arms vs placebo. See the study’s Clinical Trials page for details, including secondary endpoints.
And the findings?
While earlier reports noted that all participants had completed the study (dosings and final visits included), with “ no early discontinuations due to adverse events (AEs),” this latest data falls short.
The crux of it: The study failed to reach a statistically significant improvement in IOP vs placebo.
On the brightside, however: SBI-100 0E was found to be safe in its treatment.
And the resulting effect of this?
Skye has chosen to discontinue all clinical development, research and development, and spending related to SB-100 OE’s ophthalmology pipeline.
Yikes. So what’s next for the company?
The company will be directing 100% of its focus and “clinical development resources to its metabolic program, extending its operating runway into 2027.”
The plan: To begin dosing in a phase 2 obesity trial for Nimacimab, a differentiated CB1 inhibitor, in Q3 2024.
That’s quite a pivot.
Yes … however, the company has reportedly already set the stage for its metabolic program over the last year by “diversifying our product portfolio’s disease targets and therapeutic mechanisms, while significantly expanding our clinical and business opportunities,” stated Skye CEO and Chair Punit Dhillon.
The uniqueness of this metabolic candidate: Potential for Nimacimab to “contribute to the need for higher-quality, sustainable weight loss and better treatments for comorbid conditions amidst an incretin-biased anti-obesity therapeutic landscape,” according to Dhillon.
So that’s it for SBI-100 OE?
As far as clinical development goes, yes. However, Skye’s Chief Development Officer Tu Diep noted that the company will “continue to evaluate the full data set and intend to publish findings'' from the phase 2 SBI-100 OE study.
Translation: Stay tuned for a full rundown published in the near future!